Estágio de coordenação de estudos & atividades de monitorização e start-up de ensaios clínicos na AIDFM-Associação para a Investigação e Desenvolvimento da Faculdade de Medicina

• Autor(a) principal: Costa, Mariana Marques da
• Data de Publicação: 2022
• Tipo de documento: Dissertação
• Idioma: por
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10362/148059
• topic: Clinical Studies coordination; Domínio/Área Científica::Ciências Médicas

In the scope of obtaining the master's degree in Clinical Research Management, a curricular internship was completed to consolidate and apply the theoretical knowledge acquired during the study cycle. Over one academic year and under the guidance of Doctor Inês Zimbarra Cabrita and Doctor Rita Torrão, were performed activities in coordination of clinical studies in the Cardiovascular Research Support Unit and start-up and monitoring activities, accomplished in the Contract Research Organization, AIDFM-CETERA. This report is organised into 2 major sections, the first of which presents an overview of clinical research, including a framework for the roles of a Study Coordinator and a Clinical Trial Monitor. Secondly, the topic of "Investigator-initiated Studies" is reviewed, exploring some of the key aspects related with them, including the impact of their conduct on clinical practice, funding sources and strategies and several initiatives that may enhance and simplify the development and conduct of studies with this profile. The second chapter of the report, which focuses entirely on the curricular internship, presents the objectives defined for the internship and the host institutions mentioned above. Subsequently, are described the activities of coordination, start-up and monitoring of clinical studies performed during this period.